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AgVetLink: Number 56, June 2006

All about the packaging...

We have had several queries about packaging requirements recently. Here is a reminder of some basic parts of our packaging policy.

Pack sizes

Provided the appropriate data and information are supplied, the ACVM Group will approve a range of pack sizes at initial registration. From that point, all pack sizes with a risk profile that falls within the assessed range (such as the same packaging material) are considered approved.

For existing products applications can be made to approve a range of pack sizes as a normal C3, with referencing to data already on file, or via the provision of additional information. In either case, the ACVM Group requires notification of the actual pack sizes being marketed in the form of a formal letter, which must be provided each time a new pack in the approved range is introduced to the market. In addition, any subsequent applications requiring a product data sheet to be submitted must state the marketed pack sizes as well as the approved range. Labels for additional packs do not require approval provided the content does not differ from that already approved.

For new packs falling outside of the approved risk profile, new data and a C3 application (and fee) are required.

Multiple packs

It is common practice for veterinary medicine products to be packaged in foils, blisters, pouches and vials and sold as multiple lots in containers.  Although it is less common for vertebrate toxic agent and plant compound products, smaller individually packaged bottles of product may be sold in bulk lots in a similar fashion. 

Where units are individually packaged (e.g. tablets in foils or blisters, vaccine vials, bottles of product) and then included in multiple numbers in containers, the actual number of individual units included per container does not need to be stated on the label approved by the ACVM Group provided the container does not contribute to the stability profile of the product. 

In consequence, where changes are made to the number of individual units included per container, no formal ACVM Group approval is required provided there are no changes to the individual unit or ACVM-relevant approved label text. 

Where the container contributes to the stability profile of the product the usual policy regarding approved pack sizes (which must be identified on approved label text and for which C3 applications are required prior to changes being made) is likely to apply.